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Efficacy and Safety of Avandamet or Uptitrated Metformin Treatment in Patients with Type 2 Diabetes Inadequately Controlled with Metformin Alone: A Multicenter, Randomized, Controlled Trial

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文摘 Background: At present, China has listed the compound tablet containing a fixed dose of rosiglitazone and metformin, Avandamet, which may improve patient compliance. The aim of this study was to evaluate the efficacy and safety of Avandamet or uptitrated metformin treatment in patients with type 2 diabetes inadequately controlled with metformin alone. Methods: This study was a 48-week, multicenter, randomized, open-labeled, active-controlled trial. Patients with inadequate glycaemic control (glycated hemoglobin [HbAlc] 7.5-9.5%) receiving a stable dose of metformin (>1500 mg) were recruited from 21 centers in China (from 19 November, 2009 to 15 March, 2011). The primary objective was to compare the proportion of patients who reached the target of HbAlc <7% between Avandamet and metformin treatment. Results: At week 48, 83.33% of patients reached the target of HbAlc <7% in Avandamet treatment and 70.00% in uptitrated metformin treatment, with significantly difference between groups. The target of HbAlc <6.5% was reached in 66.03% of patients in Avandamet treatment and 46.88% in uptitrated metformin treatment. The target of fasting plasma glucose (FPG) <6.1 mmol/L was reached in 26.97% of patients in Avandamet treatment and 19.33% in uptitrated metformin treatment. The target of FPG <7.0 mmol/L was reached in 63.16% of patients in Avandamet treatment and 43.33% in uptitrated metformin treatment. Fasting insulin decreased 3.24 ± 0.98 μU/ml from baseline in Avandamet treatment and 0.72 ±1.10 μU/ml in uptitrated metformin treatment. Overall adverse event (AE) rates and serious AE rates were similar between groups. Hypoglycaemia occurred rarely in both groups. Conclusions: Compared with uptitrated metformin, Avandamet treatment provided significant improvements in key parameters ofglycemic control and was generally well tolerated.
来源 Chinese Medical Journal ,2015,128(10):1279-1287 【核心库】
DOI 10.4103/0366-6999.156735
关键词 Avandamet ; Efficacy ; Type 2 Diabetes
地址

1. Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, 100044  

2. Department of Endocrinology and Metabolism, Shandong Provincial Hospital, Shandong, Jinan, 250021  

3. Department of Endocrinology and Metabolism, First Hospital of China Medical University, Liaoning, Shenyang, 110001  

4. Department of Endocrinology and Metabolism, Tianjin Medical University General Hospital, Tianjin, 300070  

5. Department of Endocrinology and Metabolism, First Affiliated Hospital of School of Medicine, Zhejiang University, Zhejiang, Hangzhou, 310003  

6. Department of Endocrinology and Metabolism, Second Affiliated Hospital of School of Medicine, Zhejiang University, Zhejiang, Hangzhou, 310009  

7. Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Sichuan, Chengdu, 610041  

8. Department of Endocrinology and Metabolism, Guangdong General Hospital, Guangdong, Guangzhou, 510080  

9. Department of Endocrinology and Metabolism, South Hospital, Guangdong, Guangzhou, 510515  

10. Department of Endocrinology and Metabolism, Beijing Tongren Hospital, Beijing, 100730  

11. Department of Endocrinology and Metabolism, Peking University Third Hospital, Beijing, 100191

语种 英文
文献类型 研究性论文
ISSN 0366-6999
学科 生物化学;内科学
基金 supported by GlaxoSmithKline
文献收藏号 CSCD:5419638

参考文献 共 14 共1页

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